Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

Description

The goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.

Conditions

Polycythemia Vera

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Study Overview

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Study Details

Study overview

The goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.

Randomized, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

Condition
Polycythemia Vera
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294-0001

Redlands

Emad Ibrahim, MD, Inc, Redlands, California, United States, 92373

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Cleveland

The Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Salt Lake City

University of Utah - Huntsman Cancer Institute - PPDS, Salt Lake City, Utah, United States, 84112

Seattle

VA Puget Sound Health Care System - NAVREF - PPDS, Seattle, Washington, United States, 98108-1532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients must have been diagnosed with PV according to the 2016 WHO criteria within 3 years before randomization
  • * Patients must have JAK2V617F-positive disease
  • * Patients with PV must meet the definition of HR for thrombosis (i.e., HR) at screening as follows:
  • * Age ≥ 60 years, and/or
  • * Prior thrombosis.
  • * Patients must be in need of treatment at screening, defined by the presence of at least one of the following:
  • * HCT ≥ 45% or HCT \< 45% with at least 1 phlebotomy performed in the 3 months before screening, or
  • * WBC count \> 10 × 109/L, or
  • * PLT count \> 400 × 109/L.
  • * Patients must have normalized HCT (i.e., HCT \< 45%) at randomization
  • * Patients pre-treated with HU with a documented history of resistance or intolerance to HU defined by the original ELN criteria
  • * Patients with a QTcF value of \> 450 msec for males and \> 460 msec for females at the Screening visit (as the mean of 3 consecutive readings 5 minutes apart in the event a first ECG demonstrates a prolonged QTcF interval); congenital or acquired history of QTc prolongation or ventricular arrhythmias, at the Screening visit
  • * Splanchnic thrombosis and/or thrombosis of the cerebral venous sinuses and/or splenectomy in the medical history
  • * Patients with clinically significant cardiovascular disease
  • * Patients with myocardial infarction, stroke or unstable angina within the 6 months prior to screening.
  • * Patients with inadequate liver or renal function at screening
  • * Uncontrolled hypertriglyceridemia at screening, i.e., triglycerides ˃ 1.5 × ULN
  • * Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy.
  • * Patients being treated concurrently with any investigational agent or prior participation in an interventional clinical study within the 30 days prior to screening or within 5 half-lives of the investigational product, whichever is longer.
  • * Pregnant or nursing women

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Italfarmaco,

Study Record Dates

2026-07